Medical clip applier safety arrangement

ABSTRACT

A medical clip dispenser apparatus for the pinching of a medical clip or staple about a portion of a mammalian body tissue. The apparatus comprises an elongated support beam having a distal end with a stationary lower housing thereon, and a distally movable hollow cinch slidably disposed on the lower housing. The cinch has a portion of a pair of closable jaws squeezably arranged therewithin. An elongated pusher has a generally cross-shaped pusher member on a distal end thereof in slidable engagement with the jaws, to keep the jaws apart from one another after a new clip has been pushed into position between the jaws.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical clip devices and more particularly toguidance and alignment arrangements on the tip of those medical clipdevices, and is co-pending with commonly assigned U.S. patentapplication Ser. No. 09/795,808, entitled “Release Mechanism for aGrasping Device” filed 28 Feb. 2001 and Ser. No. 09/934,378, entitled“Safety Locking Mechanism for a Medical Clip Device” and filed 21 Aug.2001, as all of which are incorporated herein by reference in theirentirety.

2. Prior Art

Medical clip devices are utilized to pinch and shut off a body tissue.The clip device usually comprises an elongated support arm having adistal end comprising a pair of squeezable jaws. Medical clip devicesare shown in U.S. Pat. No. 6,277,131 to Kalikow, and U.S. Pat. No.6,306,141 to Meade, each of which are also incorporated herein byreference. Typically a staple or squeezable wire is pushed tightlybetween those jaws once the jaws and “still open” staple has surroundeda body tissue to be pinched/shut off. A problem arises occasionallywherein the staple or clip may slip from those jaws as those jaws areunintentionally manipulated and the staple gets lost at the bodytreatment site.

It is an object of the present invention to provide improvement overprior art medical clip applying devices.

It is a further object of the present invention to provide a medicalclip device which minimizes any problems associated with clipmisalignment with respect to the jaws or with a possible loss of a clipby a mis-firing occurring within that clip device.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to an improvement of the jaw mechanism ofa medical clip-applying device. Such a medical clip applying devicecomprises an elongated beam having a proximal end and a distal end. Apistol-like handle is arranged at the proximal end, with a triggermechanism arranged with an elongated coupling connected to the jaws soas to permit the jaws to be squeezed together as the attending physicianpulls on the trigger. The jaws are biased into the spread-apart or openposition and have to be squeezed together for them to pinch a clip orstaple, as will be described hereinbelow.

A pusher mechanism is arranged with the handle, the pusher having adistalmost end, which sequentially pushes clips into a position betweenthe jaws before the jaws are squeezed together at the distalmost end ofthe medical clip device. The distalmost end of the pusher in thisinvention has a generally cross-shaped member, having a pair of wingsthereon. The elongated cross-shaped portion has a pair of opposedupstanding rails on the distalmost end of the crossed-shaped member.

The upstanding rails each have a proximal sloping edge which permits thecross-shaped member to be cammed downwardly and out of the way of theclip supply when the cross-shaped member is retracted proximally as itmoves, in order to engage a successive medical clip or staple to besqueezed between the jaws. The upstanding members each have a distalmostedge which engages the proximal end or bridging portion of the U-shapedclip or staple as it is pushed into the receiving tracks of the opposedjaws on the distal end of the medical clip device.

The jaws are movably supported between an upper housing half, called a“cinch”, and a stationary lower housing half called a “brace. The jawseach have an upstanding “limiting” pin on each leg thereof. Each pin isarranged to slide within a respective track disposed on an inner surfacewall of the cinch, and each pin may be lodged into a pocket at thedistal end of each track to limit or prevent inadvertent closure of -thejaws at that point. The jaw pins, when slid into the pockets in thecinch thus prevent the jaws from accidentally closing or pinching a clipor staple between those jaws and force the jaws open before the clipgoes between the jaws. The wings on the elongated cross-shaped pushmember fit into the same track in the jaws as do the generally U-shapedclips do as they are being pushed distally or forwardly and prevent thejaws from partially closing to otherwise partially squeeze a staple orclip and thus have the clip fall accidently into a patient. The outeredges of the wings slide between the jaws as they biasedly spread apartor open so as to enable it to receive the fully spread open generallyU-shaped clip as it is being pushed therebetween. This opening of thejaws and distal motion by the outermost ends of the wings of thecross-shaped member occurs as the jaws are being permitted to reopen toaccept a new, open U-shaped clip member, ready for a further clipactuation on body tissue. Those wings on the cross-shaped member and thepins on the jaws engaged in the pockets of the cinch work simultaneouslyto provide the locking open of the jaws for proper receipt of theU-shaped clip therebetween and for proper opposed alignment of the jaws.

The jaws are pushed to their squeezed-closed position by an arrangementof cam surfaces each rubbing against a surface of each leg of the jaws,the generally U-shaped (in cross section) cinch being pushed distally onthe distal end of a “closing” pushrod. The pushrod is connected to thetrigger mechanism in the proximal or handle end of the medical clipdevice.

The distalmost finger of the elongated spring is in rubbing, biasedengagement with the underside of the generally cross-shaped pushermember. The biased spring thus also keeps the elongated cross-shapedpusher member in contact with the shoulders or ledges on the inner edgesof each respective jaw and keeps the pusher member behind the clipduring loading thereof so as to prevent slipping and misfiring of thatclip. By maintaining a biased pressure against the jaws in that manner,the jaws are prevented from crossing or misaligning with one anotherwhen those jaws are being squeezed together and closing in on a U-shapedclip therebetween. The jaws are thus accurately “opposed” with respectto one another, because of their receipt of a biased pusher andalignment cross arranged therebetween.

The invention thus comprises a medical clip dispenser apparatus for thepinching of a medical clip or staple about a portion of a mammalian bodytissue, the apparatus comprising an elongated support beam having adistal end with a stationary lower housing thereon; a distally movablehollow cinch slidably disposed on the lower housing, the cinch having aportion of a pair of closable jaws squeezably arranged the therewithin;and an elongated push rod having a generally cross-shaped pusher memberon a distal end thereof in slidable engagement with the jaws, to keepthe jaws open and in alignment with one another and to concurrently pusha new clip into position between the jaws.

Each of the jaws may have an inner edge with a shoulder extendingtherealong, for guided receipt of a clip and for stabilizing receipt ofthe cross-shaped pusher member. The cross-shaped member includes a pairof wing members extending therefrom, each of the wing members matingwith the shoulder to keep the jaws spread apart after a clip has beenfed therebetween. The cross-shaped member includes a pair of wingslaterally disposed thereon, so as to slidably engage the shoulders inthe jaws to keep the jaws open when the cross-shaped member is pusheddistally, behind the clip when it is loaded, and to thus prevent thejaws from being inadvertently closed on a staple or clip therebetween.

Each of the wings may have an upstanding rail thereon, each of the railshaving a distal edge arranged to push distally a new clip in a cliptrack during distal advancement of the cross-shaped member. Each of therails may have a sloped proximal edge to permit the rails to be cammeddownwardly and out of the way of the clip track during proximal movementof the cross-shaped member.

Each of the wings may have an outer edge thereon for respectiveengagement with each of the jaws during opening of the jaws duringdistal motion of the cross-shaped member with respect to the lowerhousing. Each of the jaws has an upstanding pin thereon for slidingengagement into a pocket in the cinch to prevent accidental closing ofthe jaws.

The lower housing or brace comprises the lower side of the stationarysupport. A spring, which is an elongated member having a distalmost end,is shaped upwardly and arranged to provide a biased finger on thelowermost side of the generally cross-shaped pusher member to keep italigned and against the bridging portions of the staples or clips. Thespring has a proximal end which is bifurcated into two parallel legs.The legs are formed into a generally U-shaped configuration in alongitudinal direction. The elongated arm of the clip pusher rod runssnugly between the bifurcated legs of the spring and is kept inlongitudinal alignment thereby.

The medical clip dispenser may include the elongated biasing springsecured in the lower housing, the elongated biasing spring having adistal end which is in rubbing engagement with a lower side of thecross-shaped member so as to keep the cross-shaped member in a linebehind the clip in the jaws. The elongated biasing spring may have abifurcated proximal end, the bifurcated proximal end arranged tostraddle the elongated pusher rod for alignment of the pusher rod andthe cross-shaped member with respect to the spring.

The invention may also comprise a method for dispensing a medical cliponto a mammalian body tissue comprising: arranging a pair of closablejaws to be supported between a stationary lower housing and a movableupper housing of an elongated medical clip dispensing device; moving apusher member between the jaws to slide between the jaws as they spreadapart from one another and to concurrently push an open clip intoposition between the jaws in tracks or shoulders in the jaws; biasingthe pusher member into said tracks in the jaws to keep the jaws inalignment by an elongated biasing spring on a lower side of the pushermember; and closing the jaws together by a distally advancing cinch tosqueeze the jaws together and crimp the clip between the jaws onto abody tissue as the pusher member is withdrawn proximally from a positionbetween said jaws. The cinch has a pair of cam track arrangements eachof which includes the pocket for slidable capture and release of a pintherefrom to permit the jaws to be temporarily locked in the openposition.

The method may include arranging an outer edge of each wing on thedistal end of the pusher member into engagement with the jaws tofacilitate the keeping open of the jaws after distal movement of theclip pusher member between the jaws, and after pushing a clip intoposition between the jaws by engagement of a pair of upstanding rails inthe pusher member with a bridging portion of the clip.

The method may also include pushing a clip into position between thejaws by engagement of a pair of upstanding rails on the distal end ofthe pusher member against a bridging portion of the clip; arranging apin on an intermediate portion of each of the jaws; arranging a pair ofcam tracks in an inner surface of the cinch for slidable engagement withthe pins on the jaws; biasedly locking open the jaws by cammed motionand receipt of the pins in a pocket arrangement in a distal end of thecam tracks in the inner surface of the cinch; arranging an elongatedbiasing spring in the brace of the lower housing, the biasing springhaving a bifurcated proximal end and an upwardly directed distal end;and aligning the bifurcated end about the pusher member to maintain thepusher member in alignment with respect to the jaws; biasing the distalend of the biasing spring so as to keep the upstanding rails against thebridging portion of the clips during delivery thereof to the jaws; andengaging the pins in the cam track in the cinch to limit distal advanceand proximal motion of the cinch with respect to the lower brace.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects and advantages of the present invention will become moreapparent when viewed in conjunction with the following drawings inwhich:

FIG. 1 is a perspective view of the distal end of the medical clipdevice of the present invention;

FIG. 2 is a side elevational view, in longitudinal central section ofthe clip device shown in FIG. 1;

FIG. 3 a is a plan view of the medical clip device shown in FIG. 1;

FIG. 3 b is a side elevational view of the device shown in FIG. 3 a;

FIG. 3 c is a bottom view of the clip device shown in FIG. 3 a;

FIG. 4 is a view taken along the lines 4-4 of FIG. 3 b;

FIG. 5 a is a sectional view taken along the lines 5 a-5 a of FIG. 3 b;

FIG. 5 b is a view taken along the lines 5 b-5 b of FIG. 5 a;

FIG. 5 c is a perspective view of the cinch shown in FIG. 5 a;

FIG. 5 d is a plan view of the cinch and jaws/pins in a jaw closedposition;

FIG. 6 is a perspective view of a spring bias member of the presentinvention; and

FIG. 7 is a perspective view of the bottom of the clip device shown inFIG. 1.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings and particularly to FIG. 1, there is shownthe present invention which comprises a medical clip applying device 10comprises an elongated beam 12 having a proximal end (not shown here forclarity) and a distal end 14 fixedly secured to a stationary lowerhousing or brace 15. A pistol-like handle (not shown) is arranged at theproximal end, with a trigger mechanism arranged with an elongatedcoupling connected to a pair of jaws 16 and 18 so as to permit the jaws16 and 18 to be squeezed together as the attending physician pulls onthe trigger.

A pusher mechanism is arranged with the handle (not shown for clarity),the pusher 20, as may be seen in FIGS. 2, 3 b, 3 c, 4 and 7, has adistalmost end, which sequentially pushes staples or clips 22, as shownin phantom in FIG. 1, into a position between the jaws 16 and 18 beforethe jaws 16 and 18 are squeezed together at the distalmost end of themedical clip device 10. The distalmost end of the pusher 20 in thisinvention has a generally cross-shaped member 24, having a pair of wings26 thereon, as may be seen in FIGS. 1, 3 a and 3 c. The elongatedcross-shaped member 24 has a pair of opposed upstanding rails 28 and.30,on the distalmost end of the crossed-shaped member 24, as may be seen inFIGS. 1, 2, 3 a and 3 c.

The upstanding rails 28 and 30 each have a proximal sloping edge 32which permits the cross shaped member 24 to be cammed downwardly and outof the way of the clip supply when the cross-shaped member 24 isretracted proximally as it moves, in order to engage a successivemedical clip or staple 22 to be sequentially squeezed between the jaws16 and 18. The upstanding rails 28 and 30 each have a distalmost edge34, as best shown in FIG. 2, which edge 34 engages the proximal or“bridging” end of the U-shaped clip or staple 22 as it is pushed into anarrangement of receiving tracks 36 of the opposed jaws 16 and 18 on thedistal end of the medical clip device 10.

The jaws 16 and 18 are movably supported between an upper housing half,called a “cinch” 42, and a stationary lower housing half called a“brace” 15. The jaws 16 and 18 each have an upstanding “limiting” pin 40on each leg thereof, as may be seen in FIGS. 2, 5 a, 5 b and 5 d. Eachpin 40 is arranged to slide along a respective cam track 41 disposed onan inner surface wall 43 of the cinch 42. Each pin 40 may reside atleast partially in a “pocket” 45 at the distal end of each cam track 41to limit or prevent inadvertent closure of the jaws 16 and 18 when theyare disposed at that point (the cinch 42 fully retracted proximally),with the jaws 16 and 18 fully spread apart. The jaw pins 40, when slidinto and mate with the pockets 45 in the distal end of the track 41 inthe cinch 42 thus prevent the jaws 16 and 18 from accidentally closingor pinching a clip or staple 22 between those jaws 16 and 18. The pins40 slide along the track 41 as the cinch 42 is moved proximally anddistally. The pins 40 move toward and apart from one anothercorrespondingly, as the jaws 16 and 18 move toward and apart from oneanother. The cinch 42 has a pair of cam surfaces 57 and 59, whichslidingly receive an outer edge 61 and 63, as may be seen in FIGS. 5 aand 5 d. As the cinch 42 is caused to move distally, the jaws arepinched together by the effect of the cam surfaces 59 and 57 on thecinch 42 acting on the side edges 61 and 63 of the jaws 18 and 16. Therelative position of the cinch 42 with the jaws 16 and 18 closed, andits pins 40 in a rearward or proximal position is shown in FIG. 5 d. Thejaws 16 and 18 being open and the pins 40 in the distal pockets 45, isrepresented in FIG. 5 a. The cinch 42 is always proximally disposedrelative to the jaws 16 and 18 before the staples or clips 22 areadvanced into the tracks 36 in the jaws 16 and 18. The cinch 42 is shownmore clearly in FIG. 5 c, with a pair of locking rails 49, as also shownin FIG. 4. The rails 49 each slidably engage a shoulder 51 on the upperside of the brace S 1, as shown in FIG. 4. This securement arrangementpermits the cinch 42 to be lockably engaged with the brace 15 and securethe jaws 16 and 18, the pusher 20 and like components in a secure manneras the cinch 42 is slid relative to the brace 15 for squeezedly closingand permitting the biased self opening of the jaws 16 and 18. The jaws16 and 18 are locked into their “open” position when the pins 40 onthose jaws 16 and 18 are engaged into the pockets 45 of the tracks 41 ofthe cinch 42.

The wings 26 on the elongated cross-shaped push member 24 also fit intothe same track 36 in the jaws 16 and 18 as do the generally U-shapedclips 22 (the wings 26 entering the track 36 after the staples or clips22 are pushed therein) do as they are being pushed distally or forwardlyand prevent the jaws 16 and 18 from partially closing to undesirablysqueeze a staple 22 which might fall into a patient. The jaws 16 and 18close only after proximal withdrawal of the cross-shaped push member 24from between the jaws 16 and 18, and distal advance of the cinch 42.This movement or the cinch 42 proximally permits the jaws 16 and 18 tobe “un-pinched” and allows their self-opening by the proximally movingcinch 42, so as to allow the jaws 16 and 18 to accept a new, openU-shaped clip member 22, ready for a further clip actuation on a bodytissue “T”. The wings 26 withdraw from the tracks 36 in the jaws 16 and18 to allow closure of the jaws 16 and 18 on the clip 22 pushedtherebetween.

The jaws 16 and 18 are thus pushed to their “squeezed-closed” positionby the distally directed motion of the generally U-shaped cinch 42 onthe distal end of a “closing” pushrod 47, as shown in FIGS. 1, 2, 3 a, 3b and 5 a. The closing pushrod 47 has a proximal end (not shown forclarity) which is connected to the trigger mechanism in the proximal orhandle end of the medical clip device 10, which when actuated, effectsthe proper distal (and subsequent proximal) motion of that pushrod 47.

The lower housing or brace 15 which is disposed in an opposedrelationship to the cinch 42, comprises the lower side of the stationarybeam 12 or support channel, as may be seen in FIGS. 1, 2, 3 b, 3 c, 4and 7. The spring 50, shown in a separate perspective view in FIG. 6, isan elongated member, has a distalmost end 52 which is shaped upwardly,as seen in FIG. 2, to provide a biased finger on the lowermost side ofthe generally cross-shaped pusher member 24, again as best seen in FIG.2. The distal end 52 of the spring 50 keeps the pusher 20 right behindthe clip 22 and at the proper level therewith, so that the upstandingrails 28 and 30 on the distalmost end of the cross-shaped member 26 doesnot slip below the bridging portion of the clip 22, which otherwisewould lead to possible misfiring or jamming of the clip 22 withoutbinding to tissue “T” and possible loss of the clip 22 in the patient.

The spring 50 has a proximal end 54 which is bifurcated into twoparallel legs 56 and 58, which are formed into a generally U-shapedconfiguration in a longitudinal direction. The legs 56 and 58 each havean inner edge 65 between which the pusher member 20 is slidably guided,as may be seen in FIGS. 2, 3 c, 6 and 7. The elongated arm of the clippusher 20 extends between the bifurcated legs 56 and 58 of the spring50, as may be best seen however in FIGS. 3c and 7, to center the pusher20 and keep it in proper alignment.

The distalmost finger 52 of the elongated spring 50 adjacent the brace15, as may be seen in FIG. 2, is in rubbing, biased engagement with theunderside of the generally cross-shaped pusher member 20. The biasedspring 50 keeps the elongated cross-shaped pusher member 20 in line withthe back or bridging portion of the clip 22, The jaws 16 and 18 areprevented from crossing or misaligning with respect to one another whenthose jaws 16 and 18 are being squeezed together by the distallydirected camming force of the cinch 42 and closing in on a U-shaped clip22 therebetween. The jaws 16 and 18 are also accurately “opposed” withrespect to one another, because of their ultimate relationship with thealignment of the cross-shaped member 24 biased by the spring 50 arrangedthereadjacent.

1-11. (canceled)
 12. A method for dispensing a medical clip onto amammalian body tissue comprising: arranging a pair of closable jaws tobe supported on a stationary lower housing brace of an elongated medicalclip dispensing device; supporting said jaws between said brace housingand a movable cinch housing; moving said cinch housing proximally withrespect to said housing brace to permit said jaws to bias open withrespect to one another; pushing an open clip by an elongated pushermember into position between said jaws for receipt of said clip in anarrangement of shoulder tracks in an inner edge of each of said jaws;and moving said cinch distally with respect to said housing brace so asto pinch closed said jaws by a camming action between an outer edge ofeach of said jaws and an inner edge arrangement on inner side portionsof said cinch, so as to crimp said clip onto a body tissue.
 13. Themethod as recited in claim 12, including: arranging a cam surface onsaid outer edge of each of said jaws to permit said jaws to be cammedpinchably closed by sliding action of said cam surfaces on said jawsrelative to a pair of cam edges on said cinch, during distal movement ofsaid cinch member with respect to said brace.
 14. The method as recitedin claim 13, including: pushing a clip into position between said jawsby engagement of a pair of upstanding rails on said distal end of saidpusher member against a bridging portion of said clip.
 15. The method asrecited in claim 13, including: arranging a pin on an intermediateportion of each of said jaws; arranging a pair of cam tracks in an innersurface of said cinch for slidable engagement with said pins on saidjaws; biasedly locking open said jaws by cammed motion and receipt ofsaid pins within a pocket arrangement in a distal end of said cam tracksin said inner surface of said cinch.
 16. The method as recited in claim14, including: arranging an elongated biasing spring in said brace ofsaid lower housing, said biasing spring having a bifurcated proximal endand a biased upwardly directed distal end; and aligning said bifurcatedproximal end about said pusher member to maintain said pusher member inalignment with respect to said jaws.
 17. The method as recited in claim16, including: biasing said distal end of said of said biasing spring soas to keep said upstanding rails against said bridging portion of saidclips during delivery thereof to said jaws.
 18. The method as recited inclaim 17, including: engaging said pins in said cam track in said cinchto limit distal advance and proximal motion of said cinch with respectto said said lower brace.